Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a fNIRS

NCT ID: NCT03990831

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-09

Study Completion Date

2019-07-09

Brief Summary

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Investigators investigate the patterns of cortical activation using the NIRST in patients with peripheral neurological injury caused by lower extremity burns.

Detailed Description

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Understanding the mechanisms associated with locomotor networks may be of benefit for rehabilitation of burn victims with neurological locomotor deficits. However, the effects of peripheral neurological injury on locomotor network remains unknown. A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury.

Investigators assessed 15 patients with lower extremity burns and 11 healthy controls.

Investigators measured walking-related cortical activity using an fNIRS device at baseline and during usual walking.

Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment.

Conditions

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Walking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients with lower extremity burn : 15 patients patients with upper extremity burn : 10 patients healthy controls : 11
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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burn injury and normal patient

HbO2 PFC perfusion using fNIRS

Group Type OTHER

Functional near-infrared spectroscopy (fNIRS)

Intervention Type DIAGNOSTIC_TEST

Functional near-infrared spectroscopy (fNIRS) measurement

Interventions

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Functional near-infrared spectroscopy (fNIRS)

Functional near-infrared spectroscopy (fNIRS) measurement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* burn patients with lower extremity or upper extremity thermal injury
* patients who could walk unassisted for at least 5min.

Exclusion Criteria

* patients with critical systemic conditions
* severe cognitive impairment
* had severe pain
* unable to walk.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Hangang Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Young Joo

Department of Rehabilitation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheong Hoon Seo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hangang Sacred Heart Hospital

Locations

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Hangang Sacred Heart Hospital

Seoul, Yeongdeungpo-Ku, South Korea

Site Status

Countries

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South Korea

References

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Al-Yahya E, Johansen-Berg H, Kischka U, Zarei M, Cockburn J, Dawes H. Prefrontal Cortex Activation While Walking Under Dual-Task Conditions in Stroke: A Multimodal Imaging Study. Neurorehabil Neural Repair. 2016 Jul;30(6):591-9. doi: 10.1177/1545968315613864. Epub 2015 Oct 21.

Reference Type BACKGROUND
PMID: 26493732 (View on PubMed)

Kim HY, Kim EJ, You JSH. Adaptive locomotor network activation during randomized walking speeds using functional near-infrared spectroscopy. Technol Health Care. 2017 Jul 20;25(S1):93-98. doi: 10.3233/THC-171310.

Reference Type BACKGROUND
PMID: 28582896 (View on PubMed)

Other Identifiers

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HangangSHH-1

Identifier Type: -

Identifier Source: org_study_id

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